Consulting for clinical and regulatory affairs
For preclinical and clinical requirements we develope science-based strategies that comply with regulatory directives. Trial protocols and study designs for safety / tolerability tests and clinical studies we formulate in close coordination and collaboration with appropriate and verified clinical research organisations (CROs), physician, biometricians and you.
Paediatric application in the Paediatric Investigation Plan (PIP) and the current requirements of benefit assessment we also take into consideration.
An important milestone in your project is accomplished through coordination and monitoring of clinical projects in scientific advice meetings with regulatory authorities.
We offer the following services:
- Consulting of regulatory approval processes for clinical trials
- Approval strategies: analysis of regulatory barries and options
- Scientific advice meetings with regulatory authorities
- Creation of IMPD (Investigational Medicinal Product Dossier), trial protocol, case report form (CRF), ﬁnal report, etc.
- Pre-clinical and clinical expert reports
- Consultation of paediatric drugs:
- PUMA approvals
- Creation of Paediatric Investigation Plan (PIP), Waiver, Deferral
For your clinical study, our project management team assists in the entire process from the development of the strategy, including the Paediatric Investigation Plan (PIP), to the incorporation of the results into the approval application.
Benefits for you:
- Your project beneﬁts from experience spanning nearly 20 years
- Development of customized strategies
- Our ongoing objective: streamlining the clinical development programme
- Planning reliability through consultation with the authorities in scientiﬁc advice meetings
- Professional project planning and timely project management from clinical testing to approval